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MTS_OW100_IFU-orthogold100-US-K182682_A

Table 4

Resistance to Electromagnetic Interference

IMMUNITY test

Standard-
Specification
IEC 60601-1-2:2014

Test level

IEC 60601-1-2:2014

Compliance level for OW100

and electromagnetic
environment

– guidance

Electrostatic
discharge

IEC 61000-4-
2:2008

Contact discharge: ±8kV
and air discharge: ±2kV,
±4kV, ±8kV, ±15kV

compliance *

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least 30
%.

High frequency
electromagnetic
fields

IEC 61000-4-
3:2010

80MHz to 2.7GHz @
10V/m

80% AM at 1kHz

compliance *

High frequency
electromagnetic
fields in direct
neighborhood of
wireless
communication
devices

IEC 61000-4-
3:2010

See table 2

compliance *

Electrical fast
transient/bursts

IEC 61000-4-
4:2012

±2kV for mains cables &
±1kV for I/O cables @
100 kHz repetition
frequency

compliance *

Mains power quality should
be that of a typical
commercial or hospital
environment.

Surges

IEC 61000-4-
5:2014

±0.5kV, ±1kV & ±2kV (L-
PE and N-PE) and
±0.5kV & ±1kV (L-N) @
0, 90 and

270˚

compliance *

Mains power quality should
be that of a typical
commercial or hospital
environment.

Disturbances on
cables, induced by
high frequency fields

IEC 61000-4-
6:2013

150kHz to 80MHz @
3Vrms; 6V in ISM bands
between 150kHz-80MHz

80% AM at 1kHz

compliance *

Power frequency
(50/60 Hz)

Magnetic fields

IEC 61000-4-
8:2009

30A/m @ 50Hz or 60Hz

compliance *

Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

*no change of an essential performance criteria

Содержание OrthoGold100 OW100-US

Страница 1: ...OW100_IFU orthogold100 US K182682_A Instructions for Use OrthoGold100 Model OW100 US US 510K K182682 Revision A 2019 01 09 Caution Federal law restricts this device to sale by or on the order of a phy...

Страница 2: ...Connection 25 3 3 Changing and disconnection of applicator 26 3 4 Water Cartridge 29 3 5 Connect the Footswitch 31 3 6 Menu setup 32 4 Operating Instructions 33 4 1 Setting the Output Parameters 43 4...

Страница 3: ...ure 15 Display of the connected applicator at the OW100 24 Figure 16 Applicator drain control 28 Figure 17 Pit for water cartridge 1 29 Figure 18 Unlocked water cartridge 29 Figure 19 Inserted and loc...

Страница 4: ...that there are several error messages piled up 66 Figure 41 Example of a warning message 66 Figure 42 Example of Information Error 66 Figure 43 Transport box OW100 Closed left opened with device right...

Страница 5: ...es in which additional information and or hints to the respective circumstances are given Warning read user manual Warning Ear protection Connection assignment for the footswitch Connection assignment...

Страница 6: ...ID Refer to instruction manual booklet M002 CAUTION 0434A Manufacturer 3082 Date of manufacture 2497 Temperature 0632 Humidity 2620 Atmospheric pressure limitation 2621 Type B applied part 5840 Foot...

Страница 7: ...rthogold100 US K182682_A The following labels are attached to the device or the applicator Type plate of the basic unit exemplified Type plate of the transport box exemplified Type plate of the footsw...

Страница 8: ...8 MTS_OW100_IFU orthogold100 US K182682_A Type plate of the applicator exemplified Type plate of the cartridge exemplified Type plate of the applicator packaging exemplified...

Страница 9: ...are using devices which are sensitive to electromagnetic radiation Do not use the OrthoGold100 in confirmed or suspected pregnancy Do not use the OrthoGold100 close to the reproductive system in femal...

Страница 10: ...physicians medical specialist with adequate medical and technical experience in acoustic wave treatments Use of this device may give rise to undesirable heart reactions The patient must be continuous...

Страница 11: ...old100 is intended for the activation of connective tissue in the upper and lower extremities The OW100 generates electrohydraulic acoustic waves by discharge of high voltage spark at a submerged elec...

Страница 12: ...nector to the device The OW100 recognizes the connected applicator type automatically and shows the name on the display By means of the footswitch 6 or the acoustic wave release button at the applicat...

Страница 13: ...ket for the detachable power cable 9 Slot for the memory card only for service purpose 10 USB connection only for service purpose 11 Water cartridge Figure 3 Components and connections of the OW100 at...

Страница 14: ...ic waves delivered per treatment session However the health care provider must use their best judgment for the patient based upon anatomy and treatment area The applicator consists of the following pa...

Страница 15: ...circuit On the rear side of the device the water cartridge drawer is located Figure 5 1 The water circuit of the OW100 fulfills the following tasks Figure 5 Water cartridge of the OW100 at the rear si...

Страница 16: ...Medics Microtek Probe Drape FDA cleared in K882724 or equivalent disposable single use does not contain latex Front Side Connections Footswitch connection Figure 6 1 The footswitch connection 1 is si...

Страница 17: ...rimary fuses Use only the delivered power cable Memory card slot Figure 7 2 SD and MMC memory cards fit into the memory card slot The use is currently provided only for designated service purpose by a...

Страница 18: ...the flexible hose contain the power and water supply for the applicator The connection of the applicator happens automatically which makes the connection simple and comfortable Operating and display...

Страница 19: ...h Figure 11 By activating the footswitch acoustic waves are released The footswitch has to be connected to the connection socket at the front side of the OW100 NOTE Footswitch Use only the provided fo...

Страница 20: ...nly be operated in a horizontal position NOTE Transport box Store the transport box to have it available for further transports WARNING Visual Inspection Before using the OW100 check the device visual...

Страница 21: ...cartridge limited lifetime as labelled 1003156 1 Instructions for Use OW100 USA 8124 1 Connect power supply Connect the provided power cable with the power connection socket 1 at the rear side of the...

Страница 22: ...turning the mains key or unplugging it from the mains socket WARNING Danger of Electric Shock The device contains high voltage circuits Any repair or maintenance work performed on equipment parts must...

Страница 23: ...result in damage to the internal components that control applicator functions If hose appears to have been kinked and applicator functions fail replace the applicator immediately WARNING Inspect the...

Страница 24: ...and activates the pull in mechanism in the correct position Figure 13 Applicator connection inside view left and socket right Figure 14 Connected applicator The OW100 automatically recognizes the con...

Страница 25: ...ional mode FRD For detailed information please contact your local dealer or MTS representative NOTE When an applicator is first plugged into an OW100 device or the applicator was not used with the dev...

Страница 26: ...blue message box with the information of Applicator check in progress When starting to release acoustic waves the remaining acoustic wave counter in percentage disappears With this option there are 2...

Страница 27: ...plug completely out Clean and disinfect the applicator and send it back in its original packaging to MTS To connect the new applicator proceed as described in Section Connect the Applicator above CAUT...

Страница 28: ...yed on the screen The device performs at first a full reference drive and adjusts the electrode into position This may take up to 30 seconds after that the applicator plug will be ejected The message...

Страница 29: ...cartridge Figure 20 should be exchanged inserted The device shows a message box when the water of the water cartridge is dissipated and it is time to exchange for a new one Exchange the water cartrid...

Страница 30: ...E The water cartridge can be inserted with the device switched off Exchange of the water cartridge 1 If the applicator is filled drain it 2 Press the key field Setup in the operation menu 3 Press the...

Страница 31: ...21 Set up Menu of the OW100 3 5 Connect the Footswitch Connect the footswitch 2 to the socket 1 at the front side of the OW100 Pressing the footswitch releases acoustic waves Figure 22 Connected Foots...

Страница 32: ...old100 US K182682_A 3 6 Menu setup To get to the setup menu press Setup Figure 23 SETUP Key field In the Setup menu you can vary device internal and individual screen settings such as screen brightnes...

Страница 33: ...the up and down arrows to select the number 7 Pressing back gets you back to the operation mode with the accordant display 8 Pressing Cartridge releases the water cartridge to be able to pull it out...

Страница 34: ...evice outside of the HF shielded area of a MRI room NOTE Usage of the OW100 in living areas Due to the characteristics of the device which are characterized by the emission the usage of the device is...

Страница 35: ...used in the vicinity of or together with other equipment in a stacked arrangement If it is unavoidable to stack the device in close proximity to other equipment the OW100 should be carefully observed...

Страница 36: ...be restarted in accordance with the operating instructions Both types of break in the electrical supply will cause the equipment to go into a safe condition NOTE The OW100 uses high frequency HF techn...

Страница 37: ...lid 1 press the confirmation button 2 for 2 seconds Figure 25 Thereafter the device shows the start screen Figure 26 and subsequently the operation screen Figure 27 The device is now ready Figure 25 S...

Страница 38: ...illuminated press confirmation button in the touch wheel for 2 seconds Figure 25 The OW100 starts the self test and ends after successful testing in the operation mode Self test After switching on the...

Страница 39: ...applicator To get rid of air bubbles tilt the applicator 30 downwards and release approx 20 acoustic waves The air bubbles will be detached from the membrane and moved to the border of the reflector...

Страница 40: ...is filled 9 Press the RESET key field on the touch screen 10 Apply the probe cover Probe cover application A general purpose probe cover or sheath should be used for each patient or treatment area to...

Страница 41: ...US K182682_A Step 3 Place the applicator in the cover bag containing the ultrasound gel Make sure that the membrane of the applicator has good contact with the ultrasound gel Step 4 Pull the cover ove...

Страница 42: ...full contact between the cover ultrasound gel membrane No air inclusion Step 6 Fasten the cover with the provided rubber band or ligature to ensure secure positioning over the membrane Step 7 Apply u...

Страница 43: ...ne of the arrows 2 4 or drive the bar 3 with your finger to the desired value Push and hold leads to the so called auto repeater function That means that the value starts and runs until you remove you...

Страница 44: ...lighted 9 Display for the identification of the connected applicator and the number of available total acoustic waves Operation with the touch wheel To select a field the parameter you want to change...

Страница 45: ...level Press one of the arrow buttons under ENERGY to increase the energy right arrow or to decrease left arrow Alternatively you can also move the blue bar to the right or to the left to adjust the e...

Страница 46: ...46 MTS_OW100_IFU orthogold100 US K182682_A The Applicator The following diagram is applicable to the beam pressure maximum and the target location Figure 32 Beam pressure maximum and target Location...

Страница 47: ...IIP mJ mm2 1 0 43 0 17 0 00017 0 00015 2 0 78 0 24 0 00071 0 00056 3 1 21 0 32 0 00148 0 00117 4 1 69 0 40 0 00254 0 00205 5 2 23 0 49 0 00395 0 00328 6 2 81 0 57 0 00580 0 00493 7 3 44 0 66 0 00814 0...

Страница 48: ...74 6 0 410 0 394 0 369 0 360 7 0 513 0 499 0 463 0 456 8 0 628 0 619 0 567 0 566 9 0 756 0 754 0 684 0 690 10 0 899 0 910 0 815 0 832 11 1 061 1 088 0 964 0 996 12 1 244 1 294 1 132 1 185 13 1 451 1 5...

Страница 49: ...uency at the display Pre setting of the acoustic wave numbers Pressing the arrow keys in Interval allows you to preselect the total shot numbers for a treatment Only the preset number of acoustic wave...

Страница 50: ...e number of total acoustic waves available is 70 000 The number of remaining acoustic waves will be displayed with its actual value The number of remaining acoustic waves can be also shown in percenta...

Страница 51: ...0 acoustic waves to a specific point WARNING Take frequent breaks in treatment and move the applicator continuously to prevent bruising or cavitation Always move the handpiece over the treatment zone...

Страница 52: ...e patient based upon anatomy and treatment area Review the indications and contraindications before beginning treatment WARNING Avoid air bubbles in the scope of acoustic waves The degree of tissue da...

Страница 53: ...mber of released acoustic waves AW NOTE The footswitch will deliver continuous waves until the footswitch is no longer pressed Unlike the preset the footswitch will not stop after the release of the p...

Страница 54: ...quickly into operation again For longer downtime several days without use remove the drained applicator and store applicator and device in a dust dirt and humidity free environment See Storage section...

Страница 55: ...nfecting use a customary inorganic and non flammable disinfectant Wipe with circling motions over all surfaces of the applicator Pay special attention to the water membrane 6 1 Maintenance Maintenance...

Страница 56: ...mperature The device contains water Do not store the device at temperatures below 4 C 39 2 F Temperature 4 40 C 39 2 104 F Humidity 10 85 no condensation Atmospheric pressure 500 1060 hPa 14 76 31 3 i...

Страница 57: ...isturbances are controlled The customer or the user of the OW100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment...

Страница 58: ...1 kHz Sinus 2 0 3 28 710 704 to 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1...

Страница 59: ...quipment Due to the characteristics of the device which are characterized by the emission the usage of the device is allowed in industrial areas and hospitals CISPR11 class A When used in a living are...

Страница 60: ...tion devices IEC 61000 4 3 2010 See table 2 compliance Electrical fast transient bursts IEC 61000 4 4 2012 2kV for mains cables 1kV for I O cables 100 kHz repetition frequency compliance Mains power q...

Страница 61: ...d separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interf...

Страница 62: ...e generator General data The coupling to the treatment area happens via water membrane Principle electro hydraulic spark gap under water caused by discharge of high voltage condensers Acoustic wave re...

Страница 63: ...h 5 00 meter removable Type power cord including socket black HAWA 1008234 Footswitch manufacturer Steute Type RF 2S MED AP 2 0 meter cable removable Lifespan of OW100 10 years Applicator OP155 Charac...

Страница 64: ...has a detailed error message system Occurring errors are displayed in clear text see the section on Error Messages The following table contains possible errors without error message Table 6 Troublesh...

Страница 65: ...layed with error messages including error code There are different categories of messages This textbox means fatal error If not solved by pressing o k switch the device off and on If the error appears...

Страница 66: ...41 Example of a warning message Figure 42 Example of Information Error If several messages are displayed you can look at the previous left button or the following right button How many messages are pi...

Страница 67: ...have been performed by anyone other than the manufacturer or authorized personnel Any unauthorized changes to the device have been accomplished The device has not been used in accordance with the Inst...

Страница 68: ...plug of the footswitch 5 Put the device into the manufactures transport box A second person is necessary CAUTION Transport To avoid transport damage use only the manufacturer s box for the OW100 and...

Страница 69: ...pplications to MTS in the original packaging Note With every change of the applicator the water cartridge should also be changed Send the old water cartridge in the same packaging with applicator Figu...

Страница 70: ...be distributed or reproduced utilized or imparted to a third party without the prior written permission of MTS No observance will result in liability for damages Technical features are subject to cha...

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